Cleared Traditional

K092218 - FLEXICARE BREATHING FILTERS

K092218 is an FDA 510(k) clearance for FLEXICARE BREATHING FILTERS, manufactured by Flexicare Medical, Ltd.. The device is a Class 2 General Hospital device with product code CAH cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K092218 · Flexicare Medical, Ltd. · General Hospital
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Oct 2009
Decision
76d
Days
Class 2
Risk

K092218 is an FDA 510(k) clearance for the FLEXICARE BREATHING FILTERS. Classified as Filter, Bacterial, Breathing-circuit (product code CAH), Class II - Special Controls.

Submitted by Flexicare Medical, Ltd. (Mid Glam, GB). The FDA issued a Cleared decision on October 6, 2009 after a review of 76 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 868.5260 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K092218

510(k) Number K092218 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 2009
Decision Date October 06, 2009
Days to Decision 76 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 129d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

CAH Device Classification - Class 2, Special Controls

Product Code CAH Filter, Bacterial, Breathing-circuit
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5260
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - CAH Filter, Bacterial, Breathing-circuit

All 168
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K092218.
HYDRO-GUARD MINI BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER AND AIR-GUARD CLEAR BREATHING FILTER
K092409 · Intersurgical, Inc. · Mar 2010
BACT-TRAP HEPA MIDI
K093426 · Pharma Systems AB · Feb 2010
COMPRESSOR FILTER, MODELS AG1038831, HCF100,BF900,BF910,BF950, LL201, LL202, LL205, BACTERIA FILTER
K091363 · Ag Industries · Feb 2010
THERMOFLO HCH, THERMOFLO FILTER
K090738 · Arc Medical, Inc. · Jul 2009
70530-BACTIAL/VIRAL FILTER, 70531-HMEF, 70536-BACTERIAL/VIRAL FILTER
K091185 · Hsiner Co., Ltd. · Jul 2009
MEDISIZE BLUE, MEDISIZE GREEN, MEDISIZE RED
K081536 · Medisize BV · Jan 2009